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Cochlear Implants in Post-lingually Children: Results After 10 Years

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01400178
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : October 31, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:

Objectives: To assess a group of post-lingually children after 10 years of implantation with regard to speech perception, speech intelligibility, and academic/occupational status.

Study Design: A prospective transversal study. Setting: Pediatric referral center for cochlear implantation. Patients: Ten post-lingually deafened children with Nucleus and Med-El cochlear implants.

Interventions: Speech perception and speech intelligibility tests and interview.

Main Outcome Measures: The main outcome measures were score of Hint sentences recognition (silence and noise), speech intelligibility scores(write-down intelligibility and rating scale scores) and academic/ occupational status.

Condition or disease
Deafness Hearing Impairment

Study Design

Study Type : Observational
Actual Enrollment : 10 participants
Time Perspective: Cross-Sectional
Official Title: Cochlear Implants in Post-lingually Children: Results After 10 Years
Study Start Date : November 2009
Primary Completion Date : November 2010
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The age at evaluation was 19,3 to 29,2 years. The age at cochlear implant surgery was 5,4 to 16,10 years. The etiology of the deafness was: meningitis (5), ototoxic (1), mumps (2) and unknown (2).

Inclusion Criteria:

  • postlingually deaf
  • age at cochlear implant: < 18 years
  • more than 10 years of cochlear implant use

Exclusion Criteria:

  • other disabilities
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400178

Bionic Ear Center
Sao Paulo, SP, Brazil, 01329001
Sponsors and Collaborators
University of Sao Paulo
More Information

Responsible Party: Liege Franzini Tanamati, Doctor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01400178     History of Changes
Other Study ID Numbers: 186/2008
First Posted: July 22, 2011    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016

Keywords provided by Liege Franzini Tanamati, University of Sao Paulo:
cochlear implant
follow up

Additional relevant MeSH terms:
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms